UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056436 |
|---|---|
| Receipt number | R000064494 |
| Scientific Title | Evaluation of the eye-drop container using the flange-colored nozzles on the visibility |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2026/06/16 11:04:00 |
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Basic information
Public title
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Acronym
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Scientific Title
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Scientific Title:Acronym
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of nozzle tips of eye-drop containers using the flange-colored nozzles on the visibility, in glaucoma patients.
Basic objectives2
Others
Basic objectives -Others
visibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visibility of nozzle tips of eye-drop containers, between the colorless nozzles and the flange-colored nozzles.
Key secondary outcomes
Preference of nozzle tips between the colorless nozzles and the flange-colored nozzles.
Visibility of nozzle tips between the colorless nozzles and the flange-colored nozzles, stratified by central foveal threshold (over 31dB and under 31dB)
Preference of nozzle tips between the colorless nozzles and the flange-colored nozzles, stratified by central foveal threshold (over 31dB and under 31dB)
Patient background factors affecting to visibility and Preference (including near vision and color anomaly)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older, regardless of gender
2) Patients with glaucoma in one or both eyes, and receiving eye drop treatment
Key exclusion criteria
1) Patients with diseases that may affect visual field testing (e.g., cataracts)
2) Patients that cannot instill eye drops by themselves with disability
3) Patients who have difficulty in performing the Humphrey visual field test
4) Patients deemed by the physician to be inappropriate to participate in this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Mizoue |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
454 Shitsukawa, Toon-city, Ehime
TEL
0899605361
mizoue@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuzo |
| Middle name | |
| Last name | Okuno |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
454 Shitsukawa, Toon-city, Ehime
TEL
0899605361
Homepage URL
s.okuno024@gmail.com
Sponsor or person
Institute
Shiro Mizoue
Institute
Department
Personal name
Funding Source
Organization
SENJU Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Human Rights and Ethics for Clinical Studies
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
Tel
03-6665-0572
soudan@hurecs.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
南松山病院（愛媛県）Minami-matsuyama Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202602257703886565
Publication of results
Published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202602257703886565
Number of participants that the trial has enrolled
146
Results
Of 146 cases (mean 66.4 years), 55 were in the low-threshold group and 91 in the high-threshold group. For the primary outcome of nozzle tip visibility, 77.4% overall favored the colored-flange container over the colorless one (binomial test, p<0.0001), with no significant difference between the groups (p=0.6942; high-threshold: 79.1%, low-threshold: 74.5%). For future use preference, 72.6% overall selected the colored-flange container (p<0.0001), showing no group difference (p=0.7327).
Results date posted
| 2026 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 30 | Day |
Baseline Characteristics
Patients with glaucoma who visited the Department of Ophthalmology at Minami-Matsuyama Hospital between December 2024 and March 2025, who provided informed consent for this study, and who met the following criteria were included: men and women aged 18 years or older, with glaucoma in one or both eyes, and undergoing eye drop treatment.
Exclusion criteria consisted of patients with diseases that could affect visual field testing, those with physical disabilities to an extent that made self-instillation difficult, and those for whom performing Humphrey visual field testing was difficult.
The target eye was defined as the eye affected by glaucoma; in cases where both eyes had glaucoma, the eye with the lower central foveal threshold was selected as the target eye. If the central foveal threshold was identical in both eyes, the right eye was selected.
Participant flow
The evaluator handed the eye drop container to the participant, who then evaluated it by bringing it close to the target eye using their usual motion for instilling eye drops. The order of the eye drop containers to be evaluated was randomly assigned using an allocation management sheet.
The survey items included: regarding visibility, "Which nozzle tip is easier to see? (Colorless nozzle vs. Colored-flange nozzle)"; regarding preference for future use, "Which would you prefer to use in the future? (Colorless nozzle, Colored-flange nozzle, or No preference)." Finally, the attending physician verbally interviewed the participants to record the reasons for their choice regarding future use.
Adverse events
none.
Outcome measures
Primary Outcome Measure:
Visibility of the nozzle tip [The percentage (%) of participants who reported which nozzle tip was easier to see in a comparison between the colorless nozzle container and the colored-flange nozzle container].
Secondary Outcome Measures:
Preference for future use [The percentage (%) of participants selecting each preference option (colorless nozzle, colored-flange nozzle, or no preference)].Reasons for future use preference [Verbal interview records obtained by the attending physician].
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Visibility
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064494
